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A Clinical Trial of the Effectiveness and Safety of Software Assisting Diagnose the Intestinal Polyp Digestive Endoscopy by Analysis of Colonoscopy Medical Images From Electronic Digestive Endoscopy Equipment

A Clinical Trial of the Effectiveness and Safety of Software Assisting Diagnose the Intestinal Polyp Digestive Endoscopy by Analysis of Colonoscopy Medical Images From Electronic Digestive Endoscopy Equipment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071120
Enrollment
Unknown
Registered
2023-05-05
Start date
2023-05-10
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal polyps

Interventions

Trial Group I:AI-assisted colonoscopy (first pass) was performed first, followed by standard colonoscopy (second pass)
Trial Group II:Standard colonoscopy (first pass) was performed first, followed by AI-assisted colonoscopy (second pass).

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Age 18 to 85 years, regardless of gender. 2.Colonoscopies are required for subjects. 3.The subjects or their legal representative are able to understand the purpose of the trial, demonstrate full compliance with the trial protocol, and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1.Combined contraindications related to colonoscopy or biopsy. 2.Inadequate bowel preparation. 3.Diagnosis of colorectal cancer, familial polyposis, or a combination of known colorectal polyps. 4.Severe neurological disease or vital organ dysfunction (heart, lung, liver, kidney). 5.Acute inflammatory episodes in the abdominal cavity or intestine. 6.History of abdominal, pelvic, or anal or perianal surgery within 2 months prior to enrollment. 7.Participation in another interventional clinical trial within 1 month prior to enrollment. 8. Other conditions that, in the opinion of the investigator, should not be included in this clinical trial for the benefit of the subject.

Design outcomes

Primary

MeasureTime frame
Polyp miss rate;

Secondary

MeasureTime frame
Adenoma miss rate;Polyp per colonoscopy;Adenoma per colonoscopy;Missed Polyp per colonoscopy;Missed Adenoma per colonoscopy;Polyp detection rate;Adenoma Detection Rate;False negative rate;sensitivity;specificity;Total coincidence rate;Rate of accuracy;

Countries

China

Contacts

Public ContactAiming Yang

Peking Union Medical College Hospital

yangaiming@medmail.com.cn+86 10 69155016

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026